Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 18
Updated:4/21/2016
Start Date:November 2010
End Date:July 2015

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Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the
pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to
confirm that the exposure is comparable to adults. This study is a single dose study with
multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism
(VTE) treatment.


Inclusion Criteria:

- Pediatric subjects > 6 months and < 18 years of age at the time of administration of
study drug.

- Patients who have completed treatment of VTE, but are considered to have risk for
recurrence of VTE

Exclusion Criteria:

- Any major or clinically relevant bleeding during prior VTE treatment

- Abnormal coagulation tests within 7 days prior to study drug administration

- Severe renal impairment

- Planned invasive procedures prior to or after 24 hours of study drug administration
We found this trial at
17
sites
2130
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from 91732
St. Petersburg, FL
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7198
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from 91732
Brisbane,
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2194
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Chapel Hill, NC
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1729
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Chicago, IL
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2032
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Cleveland, OH
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1966
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from 91732
Detroit, MI
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2202
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from 91732
Durham, NC
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2103
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from 91732
Gainesville, FL
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1793
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from 91732
Indianapolis, IN
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1793
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from 91732
Indianapolis, IN
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1463
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from 91732
Little Rock, AR
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13
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from 91732
Los Angeles, CA
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13
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from 91732
Los Angeles, CA
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2449
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from 91732
New Hyde Park, NY
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21
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from 91732
Orange, CA
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2375
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from 91732
Philadelphia, PA
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2119
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from 91732
Pittsburgh, PA
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